Kornimate/medical-research-clean huggingface dataset:
prospective study to evaluate effectiveness with the nuro™ percutaneous tibial neuromodulation system in patients with oab

Conditions: Overactive Bladder

Summary: to evaluate the nuro system for the treatment of oab in drug naïve patients.

the purpose of this prospective, multicenter, single arm study is to evaluate the nuro system for the treatment of oab in drug naïve patients. the study will assess change from baseline through 12 ptnm therapy sessions in uui (urge urinary incontinence) episodes, voiding episodes, and patient reported outcomes. the study is expected to last approximately 14 weeks per subject following the enrollment visit. subjects will be exited from the study after the final study visit is complete.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. diagnosis of oab and associated symptoms of uui and qualify with at least 3 episodes of mild, moderate, or severe urgency demonstrated on a 3-day urinary voiding diary 3. experiencing uui symptoms for at least 3 months 4. no prior treatment with anticholinergics/antimuscarinics or beta 3-agonists medications to treat oab 5. willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol 6. willing and able to provide signed and dated informed consent exclusion criteria: 1. have received anticholinergics/antimuscarinics or beta 3-agonists medications to treat oab or advanced therapy treatment options for oab (botulinum toxin injections, sacral neuromodulation, or percutaneous tibial nerve stimulation/neuromodulation) 2. primary stress incontinence or mixed incontinence where the stress component overrides the urge component 3. have implantable pacemakers or implantable defibrillators 4. use of transcutaneous electrical nerve stimulation (tens) in pelvic region, back or legs 5. women who are pregnant or planning to become pregnant during the course of the study 6. characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol 7. nerve damage that could impact either tibial nerve or pelvic floor function. 8. subjects prone to excessive bleeding 9. inadequate skin integrity in the area of ptnm needle placement 10. history of diabetes unless the diabetes is well-controlled through diet and/or medications 11. have symptomatic urinary tract infection (uti) 12. participation in any research study involving or impacting gynecologic, urinary or renal function within the 4-week period prior to or plans to participate during study enrollment
genetic testing for the prevention of cancer in indigenous american communities (juniper trial)

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial is studying the genetic changes in cells associated with different types of cancer in indigenous american (ia) populations in the southwest to improve cancer screening, precision prevention, and therapeutic intervention for individual in these communities. ia tribes have much lower rates of cancer screening, have more limited access to healthcare, are more often diagnosed at later stages of disease, and have the poorest outcomes in all types of cancer when compared to any other racial and ethnic group in the united states. due to these significant cancer health disparities, ias have been understudied and little is known about the molecular characterization of tumors arising in ias. undergoing genetic testing of tumors may improve cancer outcomes in ia participants and communities.

primary objectives: i. to develop culturally appropriate, respectful, trusted, and collaborative means to engage and recruit indigenous americans (ias) affected by cancer (newly diagnosed cancer participants, participants undergoing cancer treatment, and cancer survivors) for molecular characterization of their tumors. ia. conduct direct participant engagement with cancer participants/survivors, community advisors, and partners to refine and optimize methods/processes. ib. identify, recruit, and consent eligible ia cancer participants/survivors. ic. implement tissue acquisition, epidemiologic, behavioral, and clinical data collection, conduct continuous assessment of performance benchmarks. id. return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select. secondary objective: i. translate any discoveries to improved cancer screening, precision prevention, and therapeutic intervention that can be used to enhance cancer screening and precision prevention and improve cancer outcomes in indigenous american participants and communities. outline: patients undergo collection of blood or saliva samples on study for genetic testing. patients also undergo collection of leftover tissue obtained from standard of care (soc) surgical procedure or biopsy, or stored tissue samples for genetic testing on study. patients receive the results of their genetic testing and are given resources for counseling and further care. after completion of study intervention, patients are followed up once a year up to 5 years from study registration.

Eligibility criteria:
inclusion criteria: * male or female adults \>= 18 years of age * cancer patient undergoing active treatment or a cancer survivor * self-identify as indigenous american exclusion criteria: * unable to provide informed consent * individuals who are under 18 years of age * prisoners
nbi versus indigo carmine during colonoscopy in lynch syndrome

Conditions: Lynch Syndrome

Summary: this study compares two colonoscopy techniques (with narrow band imaging versus with indigo carmine chromoendoscopy) in patients having lynch syndrome

chromoendoscopy using indigo carmine dye is recommended every 1 to 2 years in patients having lynch syndrome (ls). however, it is a time-consuming procedure, requiring a prior learning and has an additional cost, the reason why it is not yet systematically practiced in all endoscopy centers. the "narrow band imaging" (nbi) is a recent virtual chromoendoscopy technique using optical filters at the light source of the endoscope to highlight the vascular structures of the mucosa by pressing a button. nbi is currently used to better characterize dysplasia lesions in the esophageal, gastric, and colon mucosa. a new generation (3rd generation) of nbi is currently available on some endoscopes, it can deliver more brightness and contrast, and could allow for better detection of flat lesions. until today, no study has directly compared colonic chromoendoscopy with indigo carmine to virtual chromoendoscopy with nbi (3rd generation) in ls patients. the hypothesis that this research aims to verify is that the new generation nbi system might do at least as well as indigo carmine in colonic adenoma detection in ls. this study aims to compare colonoscopy with virtual chromoendoscopy using 3rd generation nbi system to chromoendoscopy with indigo carmine in ls patients, in a back-to-back, prospective non inferiority design, in which all patients will have both techniques in the following order: nbi first followed by indigo carmine.

Eligibility criteria:
inclusion criteria: * lynch syndrome with an identified mutation in one of the genes mutl homolog 1 (mlh1), mutl homolog 2 (mlh2), muts homolog6 (msh6), pms2 or epithelial cellular adhesion molecule (epcam) * age between 18 and 80 * indication of a screening colonoscopy exclusion criteria: * any sign of intestinal occlusion contra-indicating bowel preparation * history of total or subtotal colectomy * any serious medical condition contra-indicating colonoscopy under general anesthesia * pregnant or breast feeding women * any coagulation disorder contra-indicating biopsies or endoscopic resections * any history of hypersensitivity to indigo carmine * adults subject to a legal protection measure (guardianship or curatorship)

Keywords: indigo carmine chromoendoscopy narrow band imaging colonoscopy
pediatric study to access pharmacokinetics and safety of oraqix gel

Conditions: Periodontal Disease

Summary: to establish oraqix is safe when used on adolescent volunteers.

this is a single-center, uncontrolled, open-label, single administration patient study. male and female subjects aged 6 through 17 years of age in need of primary tooth extraction will be recruited from the principal investigator's database and may be supplemented by advertising. subjects who withdraw from the study prematurely will be replaced. subjects will undergo an initial screening visit at which eligibility will be determined. after completion of informed consent/assent a physical examination, vitals, 12-lead ecg, and dental examination will be conducted. a medical history will be documented and a blood sample will be collected for analysis of biochemistry, hematology and as appropriate, serum pregnancy assessment for females. subjects will return to the office approximately 1 to 10 days after visit 1 for visit 2. at visit 2, study treatment will be administered and pk blood samples will be collected for analysis, and monitored for safety parameters. up to a total of five cartridges of oraqix® will be administered to the oral cavity in the area of the tooth extraction, based on the body weight of the subject. no more than five cartridges will be dispensed, since this is the maximum dose for this agent. the final sample will be collected 4 hours after administration of study material. an abbreviated dental examination will be conducted, any adverse events (aes) will be documented and the subject will be discharged from the clinic. all subjects will be contacted by telephone approximately 24 hours after administration of study treatment. study personnel will enquire about the occurrence of any aes that have occurred since leaving the office. if appropriate, further follow-up of aes will be arranged. in the absence of any ongoing aes requiring follow up the subject will be considered to have completed the study at the completion of the telephone call.

Eligibility criteria:
inclusion criteria: * 6 and 17 and eleven twelfths * requires tooth extraction * healthy having not taken any prescription or over the counter medications within 60 days of first visit * must be a minimum of 15 kg exclusion criteria: * anesthesia required for treatment other than study material * given blood within 90 days of first visit * pregnant * allergic to local anesthetic * documented history of glucose-6-phosphate dehydrogenase deficiency * history of congenital idiopathic methemoglobinemia * does not have a loose tooth easily extracted or who, in the opinion of the investigator, is not suitable for tooth extraction using only topical anesthetic
combination chemotherapy in treating patients with stage iiib or stage iv non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining cisplatin with gemcitabine in treating patients who have stage iiib or stage iv non-small cell lung cancer.

objectives: i. determine the efficacy of the combination of cisplatin and gemcitabine in terms of response rate and progression free survival in patients with stage iiib or iv non-small cell lung cancer. ii. evaluate this treatment regimen in terms of toxicity and quality of life in these patients. outline: this is a multicenter study. patients receive gemcitabine iv over 30 minutes and cisplatin iv over 1 hour every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. patients with no disease progression following 6 courses of therapy receive an additional 6 courses of therapy. quality of life is assessed prior to each course and then every 3 months. patients are followed every 3 months until death. projected accrual: a total of 37-83 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed non-small cell lung cancer locally advanced stage iiib (t4, nx, m0, or tx, n3, m0) or metastatic disease stage iv unresectable disease following cell types eligible: epidermoid cell large cell adenocarcinoma bidimensionally measurable disease unresectable recurrence after primary surgery allowed no brain metastasis patient characteristics: age: 18 to 75 performance status: who 0-2 life expectancy: at least 3 months hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hemoglobin at least 10 g/dl hepatic: ast and alt no greater than 3 times upper limit of normal (uln) bilirubin no greater than 1.5 times uln renal: creatinine no greater than 1.10 mg/dl cardiovascular: no uncontrolled cardiac disease other: no other significant, uncontrolled underlying medical or psychiatric condition no serious active infection neurologically stable no other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy surgery: see disease characteristics other: at least 30 days since prior experimental therapy no other concurrent experimental drugs

Keywords: recurrent non-small cell lung cancer squamous cell lung cancer large cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer adenocarcinoma of the lung
tight glycemic control with intensive insulin therapy in picu

Conditions: Critical Illness

Summary: in a previous study, the investigators showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality in adult intensive care patients. whether this intervention also improves prognosis of pediatric intensive care patients remains unknown. the current prospective, randomized, controlled study will asses the impact of intensive insulin therapy on outcome of patients in a pediatric intensive care unit. on admission patients will be randomly assigned to either strict normalization of blood glucose according age adjusted values or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl to maintain blood glucose levels between 180-200 mg/dl.

study type: interventional study study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study

Eligibility criteria:
inclusion criteria: * children admitted to the pediatric intensive care unit and anticipated to require intensive care for at least 24 hours exclusion criteria: * expected stay \< 24 hours * therapy restriction upon admission * no informed consent * other study enrollment

Keywords: tight glycemic control with intensive insulin treatment versus conventional glycemic control in infant or child in icu
vasculitis illness perception (vip) study

Conditions: Wegener Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome; Polyarteritis Nodosa; Giant Cell Arteritis; Takayasu's Arteritis; Henoch-Schoenlein Purpura; Behcet's Disease; CNS Vasculitis

Summary: the purpose of this study is to learn about how patients with vasculitis think about their illness and to assess to what extent patient perceptions of illness are associated with physical, mental, and social functioning

all patients enrolled in the vasculitis clinical research consortium's contact registry were invited via email to participate in this study. the contract registry includes people who self-identify as having one of the following types of vasculitis: granulomatosis with polyangiitis (wegener's), microscopic polyangiitis, churg-strauss syndrome, polyarteritis nodosa, takayasu's arteritis, giant cell arteritis, behcet's disease, henoch-schöenlein purpura, or cns vasculitis. people voluntarily enroll in this registry with the understanding that they will receive information about clinical studies for which they might be eligible. the introductory email included basic information about the study and all of the required elements for informed consent in a brief format. once participants agreed to participate in the study, then they were directed to the online questionnaire. when completing the questionnaire, patients were asked a series of questions. some of the follow-up questions depended on initial answers. the questionnaire content was included as an appendix. the online questionnaire version was thoroughly tested for usability. it was expected that most participants would require approximately 20-30 minutes to complete the questionnaire. the survey data is stored by the rare diseases clinical research network data management and coordinating center (dmcc) at the university of south florida. the data is de-identified. names or other personal health information are not be collected.

Eligibility criteria:
inclusion criteria: * enrolled in vcrc contact registry * patient reported diagnosis of granulomatosis with polyangiitis (wegener's granulomatosis), microscopic polyangiitis, churg-strauss syndrome, polyarteritis nodosa, giant cell arteritis, takayasu's arteritis, henoch-schöenlein purpura, behçets disease, and cns vasculitis * 18 years of age or older * english speaking exclusion criteria: * inability to provide informed consent and complete survey
identification of corticomedullary differentiation along different stage of pregnancy

Conditions: Nephropathy

Summary: corticomedullary differentiation (cmd) abnormality (absent/reversed) is a parameter that can indicate possible nephropathy. the evolution of cmd across gestation had not been well established. devrendt et al demonstrated the presence of cmd in all fetuses older then 20 weeks. in our study we would like to determine the exact timing of it's sonographic visualisation. this is a prospective study recruiting women between 14-24 week gestation during routine ultrasound screening. a midsagittal image of each kidney will be taken by a single sonographer and examined for the presence of the cmd by two other sonographers blinded to gestational age.


Eligibility criteria:
inclusion criteria: * pregnant women 14-24 weeks * singleton pregnancy * appropriate for gestational age fetuses * well dated pregnancy exclusion criteria: * family history of renal disease * small /large for gestational age fetuses * known structural anomalies * unknown dating
fibroids and the risk of miscarriage: a prospective observational study in an early pregnancy population

Conditions: Fibroid; Miscarriage in First Trimester; Miscarriage in Second Trimester

Summary: the aim of this observational study is to whether fibroids increase the risk of miscarriage in women in our early pregnancy population. we will be collecting lots of data detailing other factors, which may have an impact on overall health and on the risk of miscarriage (this includes age, weight, use of vitamins or progesterone supplements, postcode which is linked to national deprivation scoring status and employment status). by collecting all this data, we hope to remove the effect of other factors and purely assess the effect that the fibroids have on the outcome in early pregnancy. we will also be looking closely at whether the location, number or size of the fibroids can affect the pregnancy too and following up women at 24 weeks via phone. we will also look at other secondary outcomes such whether women with fibroids experience symptoms of pain or bleeding in the first or second trimester more so than their control counterparts. we will also look at the value of uterine volume as a surrogate marker of fibroid mapping. once all the data has been analysed, we will be able to assess whether fibroids lead to an increased risk of miscarriage. we hope that this information will be useful in counselling women affected by fibroids in the pregnancy.


Eligibility criteria:
inclusion criteria: * all women presenting at less than 10 weeks gestation either by last menstrual period or by transvaginal scan findings with an early intrauterine or ongoing pregnancy on scan exclusion criteria: * women declining participation and follow up * women wishing to pursue termination of pregnancy * women who refuse transvaginal scan * multiple pregnancy * ectopic pregnancy * pregnancy of unknown location * embryonic demise * under 16 * unable to understand - interpreting services will be used such as language line if required.

Keywords: fibroid miscarriage
systematic nt-probnp and ecg screening for atrial fibrillation among 75 year old subjects in the region of stockholm, sweden - strokestop ii

Conditions: Atrial Fibrillation; Stroke

Summary: strokestop ii will study if the biomarker nt-probnp together with single-lead ecg can be used as a primary population screening tool for silent atrial fibrillation, and builds on previous results from the strokestop study.


Eligibility criteria:
inclusion criteria: * individuals born 1940 and 1941 residing in stockholm at the time of inclusion exclusion criteria: * not fulfilling the inclusion criteria

Keywords: screening stroke prevention cost effectiveness